GB 24788-2009Limits for the removable surface powder and the water-extractable protein of medical gloves (English PDF)

1 Scope

This standard specifies the limits for the removable surface powder and for the water-extractable protein of medical gloves, together with the corresponding test methods and the marking.

It applies to the gloves used in medical practice, including the examination gloves and the surgical gloves, whether powdered or powder-free.

Why the two limits exist

The donning powder does not stay on the glove. It becomes airborne when the glove is put on and removed, it carries latex protein with it into the air of the operating theatre, and it enters the surgical wound, where it has been implicated in adhesion formation and in granuloma.

The water-extractable protein is the antigen behind the type I latex allergy that developed into an occupational disease among theatre and laboratory staff. Limiting it at the product is the only control that reaches every user, which is why this is a mandatory standard rather than a recommended one.

Requirements and test methods

Clause 4 sets the numerical limits for the removable surface powder and for the water-extractable protein, and sets the threshold below which a glove may be described as powder-free - a claim with a number behind it, not a marketing term.

Clause 5 gives the test methods: the removable surface powder is determined by washing the glove and gravimetrically recovering what comes off, in accordance with GB/T 21869-2008, and the water-extractable protein is determined on an aqueous extract of the glove by the modified Lowry method of GB/T 21870-2008, the same method used internationally for this purpose. Clause 6 sets what the marking must declare.

About this edition

GB 24788-2009 is the current edition. It was issued on 15 December 2009 and has been in force since 1 October 2010.

The interval between issue and effect is the transition period. It exists so that producers, laboratories and buyers can requalify products, revise procedures and use up documentation before the new text becomes the one that applies. The date on this page is the official one from the record of the Standardization Administration.

Classification and status

GB 24788-2009 is classified under ICS 11.140. ICS is the International Classification for Standards, the same scheme used by ISO and by the national bodies of most countries, which is what allows a Chinese standard to be placed beside its foreign counterparts on subject rather than on number.

Its Chinese Standard Classification code is CCS C 31. CCS is the domestic scheme, a letter for the sector and two digits for the subject within it, and it is the code by which the standard is filed and searched in China.

The GB prefix marks a mandatory national standard. Compliance is required by law within China: it applies to what is made, sold or imported there, and an inspection body will judge a product against it whether or not a contract names it.

How a Chinese national standard is set out

Chinese national standards are drafted to the rules of GB/T 1.1, which fixes the order in which a standard is set out. The document opens with a foreword recording the issuing bodies, the relationship to any previous edition and the technical committee responsible for it. Clause 1 is the scope. Clause 2 lists the normative references — the other standards that have to be applied together with this one, and without which its requirements cannot be met. Clause 3 gives the terms and definitions. The technical clauses follow: the requirements themselves, the test or measurement methods by which conformity is established, the inspection rules that say how a lot is sampled and judged, and, for a product standard, the provisions on marking, packaging, transport and storage. Annexes, normative or informative, come last.

GB 24788-2009 runs to 15 pages in the English translation. What is delivered is the complete document in that order: every clause, every table, every figure and every annex of the Chinese original, with the same numbering, so that a reference to a clause number in a contract or a test report points to the same place in both languages.

About this English translation

The English edition of GB 24788-2009 is a full translation of the official Chinese text, not a summary, an abstract or a machine rendering left unchecked. Clause and subclause numbers, table and figure numbers and annex letters are those of the original, because they are what a specification, a purchase order or a test report cites.

Technical terms are translated against the vocabulary standards of the same field, so that a term used in GB 24788-2009 reads the same way as in the other Chinese standards it is used beside. Where a term has an established English form in an ISO or IEC document on the same subject, that form is used; where China's term has no foreign counterpart, it is translated literally and the Chinese is kept alongside it rather than replaced by an approximation.

Quantities, units and symbols are carried over unchanged. Chinese standards use SI, so a value in the translation is the value in the original document, not a conversion, and a limit read from the English text is the limit that will be applied by a Chinese inspection body reading the Chinese one.

This page is compiled from the official publication record: the standard number and both titles, the issuing bodies, the dates of issue and effect, the ICS and CCS classification. The requirements, limits, tables and test conditions are in the document itself.